APHID- Primary Care Accuracy Study

May 9, 2014 updated by: Blake Lesselroth

APHID- Sensitivity and Specificity of a Medication Reconciliation Technology - A Primary Care Randomized Controlled Trial

We are studying patients' abilities to correctly identify the prescription medications they are taking. We are interested in understanding what tools will help patients correctly identify their medications. People participating in this study will be asked to either review a paper printout of their medication list or a computer program with their medications. The program will show the names and pictures of the medications. In either situation, participants will be asked to indicate if they are taking the medications as prescribed. We will then compare reported adherence between each medication review process. Participation may help the program developers improve the product.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The trial compares a paper-based medication adherence questionnaire to an electronic medication adherence questionnaire. Results from each arm will be compared to the ambulatory medication list on file with the clinic and a separate medication review interview conducted by a trained clinician. We intend to compare adherence patterns and medication use discrepancy rates between each approach. This data will help us to determine what strategies work best to solicit an accurate medication history from the patient.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239-2999
        • Portland Vamc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Veteran with Primary Care appointment at Portland VA
  • Three or more medications in medication profile

Exclusion Criteria:

  • Visual impairment
  • Upper extremity neuromuscular impairment
  • Cognitive impairment
  • Unable to speak and read English
  • Never been seen at a VA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Paper
Usual care -medication review on paper
Experimental: Computer
Medication review software with pictures
Other: Medication review software with pictures
The intervention is a self-service software program that displays each prescription on screen along with an image of the pharmaceutical product. Patients must use response buttons to describe adherence patterns and to advance through the questionnaire items.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of medication discrepancies from the reference standard
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blake Lesselroth

Investigators

  • Principal Investigator: Blake Lesselroth, MD, MBI, PVAMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 08-0308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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